Innovative pediatric clinical trials

The KidsCAN Trials Steering Committee has engaged PERC to test innovative clinical trial methods with a carefully selected set of four pediatric trials, using a centralized trial management structure and recruiting at 6 pediatric emergency departments in four provinces. The trials were chosen based on their potential to benefit from innovative methods as well as on the prevalence of the conditions they address.

The No OUCH trial will use a patient preference approach to randomization to evaluate the comparative effectiveness of ibuprofen alone, or in combination with acetaminophen or hydromorphone, in clinical pain relief for suspected fractures.

The Ondansetron Study is a pragmatic trial that will evaluate the safety and efficacy of multiple doses of ondansetron administered post-discharge to children with acute gastroenteritis.

The INK Study will evaluate the use of inhaled versus intravenous ketamine as a less painful experience in procedural sedation as it correlates with child satisfaction and healthcare team morale.

The BIPED trialbuilds on previous evidence and will definitively confirm whether combination therapy with epinephrine and dexamethasone is effective in treating bronchiolitis and reducing infant hospitalizations.

These four conditions (suspected fractures, acute gastroenteritis, procedural sedation, and bronchiolitis) are estimated to affect over 17,300 children across our 6 recruiting sites every year. These trials will serve as proof of concept and enable us to build capacity in the design, conduct, and reporting of pediatric clinical trials that could be applicable to any pediatric subspecialty. The study team, led by Dr. Terry Klassen, was awarded a SPOR Innovative Clinical Trials multi-year grant by CIHR.

Neonatal intensive care unit trials

KidsCAN Trials has partnered with CNN to create opportunities for researchers to conduct trials in the neonatal population using centralized clinical trial data systems and to leverage the CNN database to track pragmatic clinical outcomes. The CNN database is a rich source of data, but could not readily support a Health Canada regulated trial as it is currently operationalized with the need to document safety outcome measures in real time. To allow for this, a clinical trial data capture system is required. KidsCAN Trials has implemented and continues to develop information systems to support clinical trial data collection for data elements that may be required in real time. This linkage of neonatal clinical and research data supports clinical care, quality improvement, and the needs of prospective clinical trials that are so important in this population.